NICE issues negative decision on Leqembi
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has announced that Japanese drugmaker Eisai (TYO: 4523) and US biotech Biogen (Nasdaq: BIIB) Leqembi (lecanemab) has not been recommended for use in the National Health Service (NHS) in England.
In August last year, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for the drug on the basis is of its safety, for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. However, without endorsement by the NICE, Leqembi is only available to people prepared to pay for the drug themselves, and is not available for NHS use.
Eisai said it will appeal against this decision and categorically stands by the clinical and cost effectiveness of lecanemab in its licensed indication, adding that it remains committed to achieving equitable access to lecanemab for eligible patients in the UK.
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